DEXMEDETOMIDINE FILM,SUBLINGUAL
Clinical Criteria Summary
Indication
- Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Dosing & Formulation
- Sublingual film: 120 mcg and 180 mcg strengths.
- Self-administered medication.
Efficacy & Place in Therapy
- Efficacy established for reducing mild to moderate agitation; efficacy of the 120 mcg and 180 mcg doses is comparable, with slightly greater Positive and Negative Syndrome Scale-Excited Component (PEC) total score reduction observed with the 180 mcg dose.
- Safety and effectiveness have not been established beyond 24 hours from the first dose.
- Efficacy compared to alternative treatments has not been established.
- May be considered for patients with mild to moderate acute agitation associated with schizophrenia or bipolar disorder who cannot tolerate PRN antipsychotics or benzodiazepines.
Safety, Precautions & Contraindications
- Avoid use in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope.
- Avoid use in patients with risk factors for prolonged QT interval.
- Common adverse reactions include somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.
- Other warnings/precautions include bradycardia, QT interval prolongation, risk of withdrawal reactions, and tolerance/tachyphylaxis.
Special Considerations
- Abuse potential is not yet understood; may not be suitable for patients with comorbid substance use disorder (SUD).
- Study populations were cooperative enough for self-administration and informed consent, which may not represent typical PRN agitation populations on psychiatry units or in emergency departments.